NEILMED ANTI-ITCH- anti-itch spray spray 
NeilMed Pharmaceuticals Inc.

----------

NeilMed Anti-Itch Spray

Directions:

Shake well – adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily - children under 2
years of age: ask a doctor – to apply to face, spray into palm of hand and gently apply

Warnings:

For external use only.
Flammable: Do not use while smoking or near heat or flame
Do not use: In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and seek medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F
Ask a doctor before use if you are using any other hydrocortisone or corticosteroid product.
Stop use and ask doctor if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Inactive Ingredients:

Citric Acid, Disodium EDTA, Glycerin,Poloxamer 407, Polysorbate 20, SD Alcohol 40-B,USP grade purified Water.

Uses:

Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Drug Facts: Purpose


Anti-itch

Drug Facts:


Active Ingredient
Hydrocortisone 1.0%

NeilMed Anti Itch Spray

NeilMed Anti-Itch Spray

NEILMED ANTI-ITCH 
anti-itch spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-239
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-239-0190 g in 1 CAN; Type 0: Not a Combination Product11/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/11/2020
Labeler - NeilMed Pharmaceuticals Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-239)

Revised: 1/2024
Document Id: 0eb0a47d-4c98-a632-e063-6394a90a29dd
Set id: b3d34d9e-85d9-df4e-e053-2a95a90ac8d9
Version: 3
Effective Time: 20240111
 
NeilMed Pharmaceuticals Inc.